Menadione Topical Lotion in Treating Skin Discomfort and Psychological Distress in Patients With Cancer Receiving Panitumumab, Erlotinib Hydrochloride, or Cetuximab

A Randomized, Double-Blind Placebo-Controlled Exploration of a Topical Menadione-Containing Lotion to the Face for Prevention and Palliation of Epidermal Growth Factor Receptor Inhibitor-Induced Cutaneous Discomfort and Psychological Distress

This clinical trial studies menadione topical lotion in treating skin discomfort and psychological distress in patients with cancer receiving panitumumab, erlotinib hydrochloride, or cetuximab. Menadione topical lotion may prevent rash or other skin discomfort and help alleviate psychological distress and pain in patients receiving treatment with panitumumab, erlotinib hydrochloride, or cetuximab

Study Overview

• Status: Active, not recruiting
• Conditions: Pain; Malignant Neoplasm; Dermatologic Complications
• Intervention / Treatment: Other: questionnaire administration; Other: placebo; Drug: menadione topical lotion; Procedure: management of therapy complications

Detailed Description

PRIMARY OBJECTIVES:

I. Explore the effectiveness of a menadione topical lotion to the face to prevent cutaneous and psychological discomfort from epidermal growth factor receptor (EGFR) inhibitors.

SECONDARY OBJECTIVES:

I. Explore the adverse event profile of a menadione topical lotion to the face to prevent rash from EGFR inhibitors.

II. Explore whether rash or adverse events worsen over a 4 week period after this 4-week intervention.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients apply menadione topical lotion twice daily (BID) for 28 days.

ARM II: Patients apply topical placebo lotion BID for 28 days.

After completion of study treatment, patients are followed up for 4 weeks.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic Campus in Arizona
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 years or older.
• Patient scheduled to start an epidermal growth factor receptor inhibitor (must be one of these three: panitumumab, erlotinib, cetuximab) within the next 3 days or patient has already started the epidermal growth factor receptor inhibitor but has not been on it for longer than 3 days and has no signs or symptoms potentially suggestive of EGFR inhibitor toxicity.
• Ability to reliably apply Menadione Topical Lotion / placebo twice a day to the face.
• Ability to complete questionnaire(s) by themselves or with assistance.
• Negative pregnancy test (serum or urine) done ≤ 7 days prior to registration, for women of childbearing potential only.
• Willing to have photographs taken to assess rash.

Exclusion Criteria:

• Any active facial and/or chest rash, including adult acne, at the time of randomization.
• Cutaneous metastases, skin cancer, or a history of precancerous skin lesions involving the face and/or chest.
• Use of topical corticosteroids on the face and/or chest at the time of study entry or their anticipated use in the next 8 weeks.
• Any type of ongoing therapy for rash.

• Any of the following:

  • Pregnant women
  • Nursing women
  • Men or women of childbearing potential who are unwilling to employ adequate contraception since this study involves agents that have known genotoxic, mutagenic and teratogenic effects
• Use of any antibiotic at the time of study or their anticipated use in the 8 weeks immediately following study enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (lotion); Patients apply menadione topical lotion BID for 28 days.	Other: questionnaire administration; Ancillary studies; Drug: menadione topical lotion; Given topically; Procedure: management of therapy complications; Given menadione topical lotion; Other Names: complications of therapy, management of
Placebo Comparator: Arm II (placebo); Patients apply topical placebo lotion BID for 28 days.	Other: questionnaire administration; Ancillary studies; Other: placebo; Given topically; Other Names: PLCB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to Week 4 Face Pain Score Measuring Cutaneous Discomfort	Change from baseline to Week 4 Face pain score measuring cutaneous discomfort. Face pain scale question ("How would you describe how your face feels?") with a 0-10 Face Pain Scale, where 0 = No pain/burning and 10 = worst possible pain/burning.	From Baseline to Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number of Patients Experiencing Worst Toxicity	The number of patients experiencing treatment-related adverse events (toxicities) is reported below. The maximum grade toxicity (worst toxicity) is reported by arm.	Up to 8 weeks
Long-term Cutaneous Discomfort as Measured by the Change From Baseline in Face Pain Scale at 4 Weeks (Treatment-regimen Estimand)	Least Squares mean (LS) of the Face Pain Scale change from baseline at week 4 was adjusted by treatment, week, race, gender, age (<=50 years/>50 years), and EGFR, via a MMRM analysis. Face pain scale question ("How would you describe how your face feels?") with a 0-10 Face Pain Scale, where 0 = No pain/burning and 10 = worst possible pain/burning.	Baseline, 4 weeks
Long-term Psychosocial Discomfort as Measured by the Change From Baseline in Psychological Distress Score at 4 Weeks (Treatment-regimen Estimand)	Least Squares mean (LS) of the Psychological Distress Score change from baseline at week 4 was adjusted by treatment, week, race, gender, age (<=50 years/>50 years), and EGFR, via a MMRM analysis. Psychological Distress question ("How often have you been bothered by embarrassment about your face?") with a 0-6 scale, where 0 = Never bothered and 6 = Always bothered.	Baseline, Week 4

Collaborators and Investigators

• Sponsor: Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): May 11, 2013
• Study Completion (Anticipated): March 31, 2025

Study Registration Dates

• First Submitted: June 27, 2011
• First Submitted That Met QC Criteria: July 12, 2011
• First Posted (Estimate): July 13, 2011

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: MC10C9; NCI-2011-01047 (Registry Identifier: CTRP (Clinical Trial Reporting Program))